Triacetoxyvinylsilane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Remarks:

in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05.08.1988 to 14.12.1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Three minute exposure, but this is acceptable in light of the severity of the findings. No test substance purity.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Triacetoxyethylsilane

EC Number:

241-677-4

EC Name:

Triacetoxyethylsilane

Cas Number:

17689-77-9

Molecular formula:

C8H14O6Si

IUPAC Name:

ethylsilanetriyl triacetate

Constituent 2

Reference substance name:

triacetoxy(ethyl)silane

IUPAC Name:

triacetoxy(ethyl)silane

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, France
- Age at study initiation: 'Adult'
- Weight at study initiation: 2.4-2.7 kg
- Housing: Individual in polystyrene cages
- Diet (e.g. ad libitum): 150 g per animal per day
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least seven days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5-23
- Humidity (%): 38-75
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 07.09.1989 To: 21.09.1989

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

3 minutes

Observation period:

14 days

Number of animals:

Six males

Details on study design:

TEST SITE
- Area of exposure: Back and flanks
- % coverage: No data
- Type of wrap if used: Semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Equivalent to Draize.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.6

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Some burning noticed from 24 hours. Grade 4 erythema by Day 7 and still apparent on Day 14. Burning and dryness on Day 14.

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: By Day 14 there was no erythema, but there was dryness and desquamation. Burns observed.

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3.3

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: By Day 14 there was still grade 4 erythema, burns, dryness and desquamation. Burns observed.

Results 4

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: On Day 14 there was desquamation and dryness.

Results 5

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: On Day 14 there was Grade 1 erythema, burns, desquamation and dryness. Burns observed.

Results 6

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: On Day 14 there was Grade 1 erythema, dryness and desquamation. Burns observed.

Results 7

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days.

Results 8

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.6

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 9

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3.6

Max. score:

4

Reversibility:

fully reversible within: 14 days.

Results 10

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours.

Results 11

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 7 days.

Results 12

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 7 days.

Irritant / corrosive response data:

Grade 2 erythema and edema were observed in all animals within the first hour after dressing removal. The overall reactions peaked between 24 and 48 hours after dressing removal. By 72 hours the edema began to reverse in all of the animals. However, erythema persisted for longer, such that two of the animals still had Grade 4 erythema on Day 14. Burns of varying sizes (as a proportion of the initial test area) were observed in five of the six exposed animals.

Other effects:

None

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Conclusions:

In a non-guideline study that was comparable to OECD 404 and in compliance with GLP, triacetoxyethylsilane was corrosive to the skin of rabbits. In this study the skin was exposed under semi-occlusive conditions for three minutes. Although this exposure period does not comply with current guidelines, it was long enough to show the corrosive nature of the test substance and the study is therefore considered to be reliable. Grade 2 erythema and edema were observed in all animals within the first hour after dressing removal. The overall reactions peaked between 24 and 48 hours after dressing removal. By 72 hours the edema began to reverse in all of the animals. However, erythema persisted for longer, such that two of the animals still had Grade 4 erythema on Day 14. Burns of varying sizes (as a proportion of the test site) were observed in five of the six exposed animals.